Individual Differences in Gait and Osteoarthritis Pain

NCT07308873 | Recruiting DMC

• 2 other identifiers: STUDY250800271R01AR086796-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to look at inter-individual differences in knee osteoarthritis (OA) walking pain and performance. The main questions this study aims to answer are: Why do some people with knee osteoarthritis have more severe disabling pain than others, even though the degenerative changes in their knees are similar? What are the factors that contribute to walking pain in people with knee osteoarthritis? Participants will complete surveys, perform physical function tasks, get a knee X-ray and MRI, undergo non-invasive brain imaging, and undergo sensory testing.

Conditions

Chronic Pain; Chronic Knee Pain; Knee Osteoarthritis (OA)

Outcome Measures

Primary Outcomes (1)

• 6 minute walk test pain intensity

  Pain intensity on numeric rating scale (0-10) during and around the time of the 6-minute walk test.

  6 minutes

Secondary Outcomes (1)

• Distance walked in the 6-minute walking test

  6 minutes

Other Outcomes (6)

• Quantitative sensory testing

  2-3 hours

• Physical function performance and pain

  2-3 hours

• Brain imaging

  2-3 hours

Study Arms (1)

Chronic knee pain with knee osteoarthritis

Adults 45-80 years old who have moderately severe knee osteoarthritis. They must have experienced knee pain for greater than 6 months and rate their daily knee pain at \>3 on a 0-10 numeric rating scale.

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample includes participants with knee osteoarthritis of at least moderate pain severity and radiographic evidence of significant knee joint degeneration. Participants will be recruited from research registries (Pitt CTSI Pitt+Me) and clinics with a high volume of knee osteoarthritis patients, including orthopedic and pain management clinics. Eligibility criteria are designed to study knee osteoarthritis pain around the time of walking. Therefore, some comorbidities and pain conditions are allowed if knee osteoarthritis is the primary pain condition, but other painful conditions are not allowed due to a significant confounding effect on the study. Concurrent knee interventions, such as injections, have different expected time courses of treatment effects. The exclusion criteria timepoints for each intervention are meant to enroll participants at a relatively stable periods of time after the interventions, so that pain and function do not change dramatically across Study Visits.

You may qualify if:

• Knee pain for greater than 6 months.
• Moderate-to-severe knee pain (\>3/10) due to osteoarthritis, as defined by American College of Rheumatology and EULAR diagnostic criteria, on \>50% of days in the past month.
• KL grade 2-4 indicating significant degenerative changes on knee X-ray.
• years old

You may not qualify if:

• Inflammatory arthritis (e.g. rheumatoid arthritis).
• More intense pain due to another chronic pain syndrome (e.g. fibromyalgia, hip osteoarthritis)
• Significant pain or weakness in the lower extremities due to a neurological condition (e.g. lumbar radiculopathy, paresis due to stroke)
• Acute pain that is more intense than knee osteoarthritis pain
• Current routine use of more than 15 mg oral morphine equivalents per day (use of \<15 mg OME does not exclude the participant).
• Recent new medication, exercise, behavioral, or complementary and integrative treatment started in the last month. Stable use of these treatments for greater than 1 month does not exclude the participant.
• Recent intra-articular injection of steroid or other agent (greater than 1 month does not exclude the participant)
• Recent knee radiofrequency ablation (greater than 3 months does not exclude the participant)
• Recent knee arthroscopic surgery (greater than 3 months does not exclude the participant)
• History of knee replacement or open knee surgery on the index knee, defined as the more painful knee on average over the last month.
• Inability to walk or climb stairs without significant assistance (e.g. a one-person assist, use a wheel chair; however, the use of a cane does not exclude the participant).
• Inability to participate in study procedures (e.g. cognitive impairment limiting ability to understand directions, inability to understand and read English)
• Uncontrolled or unstable medical disorder preventing participation in study procedures
• History of brain surgery
• Tattoos on sensory testing sites

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, 15206, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Chronic Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benedict Alter, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benedict Alter, MD, PhD

CONTACT

412-665-8052; bea51@pitt.edu

Emma Racunas, BS

CONTACT

ecr79@pitt.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: December 30, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be shared in accordance with NIH HEAL requirements, meaning that IPD will be made publicly available after the publication of results.
• Access Criteria: IPD will be publicly available.

Locations

US (1)